Inactive ingredient search for approved drug products
Guidance for Industry
In instances where the supplier of an inactive ingredient was specified in an approved application, change to a new supplier of that inactive ingredient (e.g., change from one drug master file (DMF) holder to other DMF holder or change to a new qualified supplier).
[DOCX File]Chapter 34 of Title 54 - Virginia
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"Controlled substance analog" does not include (a) any substance for which there is an approved new drug application as defined under § 505 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355) or that is generally recognized as safe and effective pursuant to §§ 501, 502, and 503 of the federal Food, Drug, and Cosmetic Act (21 U.S.C ...
[DOCX File]User Guide Template Home
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4.3.8.Active Products with Proposed Inactive Date Report77. 4.3.9.VUID Approvals Report78. ... Search for and view drug details but cannot modify drugs nor add new drugs to the system. ... specific non generic ingredient(s), drug strength, dose form, and route of administration.
[DOC File]Department of Veterans Affairs Pharmacy Data Management ...
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This option lists all active, multi-ingredient DRUG File (#50) entries with Local Possible Dosages defined, and whose drug name has trailing spaces. ... We are using brand name products, but are not charging for brand name products. The most common DAW codes are explained as follows: ... when editing a Local Possible Dosage for an inactive drug ...
[DOC File]California Department of Industrial Relations - Home Page
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(e) “Compounded drug” means a drug that is created by combining one or more active pharmaceutical ingredients, and one or more inactive ingredients, to meet specific patient medical needs that cannot be met with FDA-approved prescription drugs, FDA-approved non-prescription drugs, or other drugs commercially available in the marketplace.
[DOC File]FDA Regulation: 21 – CFR – 314 New Drug Application
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section on each drug (ingredient), drug product (formulation and . composition), and method of use patent issued before the application is . filed with FDA and for which patent information is required to be . submitted under this section. If a patent is issued after the . application is filed with FDA but before the application is approved,
[DOCX File]Australian Public Assessment Report for Voriconazole
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A small number of IV products containing HP-β-CD have been approved in the USA, including itraconazole (Sporanox IV, discontinued), mitomycin C (Mitozytrex), and telavancin (Vibativ). The maximum IV dose of HP-β-CD in Sporanox IV was 320 mg/kg/day for 2 days, followed by 160 mg/kg/day for up to 14 days.
[DOC File]Patentability of Active Pharmaceutical Ingredients
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The foundation for most pharmaceutical products is the active pharmaceutical ingredient (API). Since pharmaceutical research is often first directed to the discovery and identification of lead compounds for development and testing, patent applications claiming chemical compounds are usually the first applications to be filed for a drug product.
[DOC File]NPC - Tripod Development
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Lists of drug names approved for human use were obtained from the FDA official publications including the Orange Book, the National Drug Code (NDC), the Drugs@FDA webpage, the Over-the-Counter (OTC) listings from the Office of Nonprescription Products, and its Substance Registration System’s Unique Ingredient Identifier (UNII).
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